piperidines and Heartburn

Topics: Antacids; Cisapride; Esophagus; Gastroesophageal Reflux; Heartburn; Histamine H2 Antagonists; Humans; Hydrogen-Ion Concentration; Life Style; Monitoring, Physiologic; Piperidines; Posture; Serotonin Antagonists

To compare the clinical efficacy of the second-generation H2RA lafutidine with that of lansoprazole in Japanese patients with mild gastroesophageal reflux disease (GERD).. Patients with symptoms of GERD and a diagnosis of grade A reflux esophagitis (according to the Los Angeles classification) were randomized to receive lafutidine (10 mg, twice daily) or lansoprazole (30 mg, once daily) for an initial 8 wk, followed by maintenance treatment comprising half-doses of the assigned drug for 24 wk. The primary endpoint was the frequency and severity of heartburn during initial and maintenance treatment. The secondary endpoints were the sum score of questions 2 and 3 in the Gastrointestinal Symptom Rating Scale (GSRS), and the satisfaction score.. Between April 2012 and March 2013, a total of 53 patients were enrolled, of whom 24 and 29 received lafutidine and lansoprazole, respectively. After 8 wk, the frequency and severity of heartburn was significantly reduced in both groups. However, lafutidine was significantly inferior to lansoprazole with regard to the severity of heartburn during initial and maintenance treatment (P = 0.016). The sum score of questions 2 and 3 in the GSRS, and satisfaction scores were also significantly worse in the lafutidine group than the lansoprazole group (P = 0.0068 and P = 0.0048, respectively).. The clinical efficacy of lafutidine was inferior to that of lansoprazole, even in Japanese patients with mild GERD.

Topics: Acetamides; Adult; Aged; Aged, 80 and over; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Heartburn; Histamine H2 Antagonists; Humans; Japan; Lansoprazole; Male; Middle Aged; Piperidines; Proton Pump Inhibitors; Pyridines; Severity of Illness Index; Treatment Outcome

This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanese patients with mild reflux esophagitis. Safety and improvement in symptoms of heartburn were also assessed.. Patients with an endoscopic diagnosis of grade A or B reflux esophagitis according to the Los Angeles classification were randomly assigned to receive lafutidine (20 mg/day), famotidine (40 mg/day), or placebo for 8 weeks.. Of the 584 patients enrolled in the study, 447 were diagnosed to have grade A or B reflux esophagitis by the Endoscopic Assessment Committee. Healing rates at 8 weeks were 71.0% (115/162) in the lafutidine group, 61.4% (86/140) in the famotidine group, and 9.7% (14/145) in the placebo group. Lafutidine was thus demonstrated to be superior to placebo and non-inferior to famotidine. As compared with placebo, lafutidine significantly improved symptoms of heartburn.. Lafutidine has a high endoscopic healing rate and improves symptoms of heartburn in patients with mild reflux esophagitis. Lafutidine is considered a promising treatment option for mild reflux esophagitis.

Topics: Acetamides; Double-Blind Method; Esophagitis, Peptic; Esophagoscopy; Famotidine; Female; Heartburn; Histamine H2 Antagonists; Humans; Japan; Male; Middle Aged; Piperidines; Pyridines; Treatment Outcome

Medication for the relief of heartburn should have the rapid onset of action required for on-demand use. We studied the inhibition of gastric acid secretion by lafutidine and rabeprazole, given in single doses to fasting and postprandial subjects.. A total of 22 healthy male, Helicobacter pylori-negative volunteers participated in this randomized, two-way crossover study. They were randomly assigned to receive a single oral dose of 10 mg lafutidine or 20 mg rabeprazole after fasting overnight (12 subjects, fasting study) or after eating a test meal (noodles, 364 kcal; protein, 10.1 g; fat, 16 g; carbohydrates, 44.9 g; NaCl, 1.1 g; 10 subjects, postprandial study). Intragastric pH was monitored continuously for 6 h after treatment. The other drug was given after a washout period of at least 7 days, and intragastric pH was similarly monitored.. In the fasting study, lafutidine sustained pH at >3 and >4 during the second, third, fourth, fifth, and sixth hours of the study for significantly longer than rabeprazole. During the first 6 h after treatment, lafutidine sustained pH at more than 2, 3, 3.5, 4, 5, 6, and 7 longer than rabeprazole. In the postprandial study, lafutidine sustained pH >3 and >4 for longer periods than rabeprazole during the third, fourth, fifth, and sixth hours of the study. During the first 6 h after treatment, lafutidine sustained pH at more than 2, 3, 3.5, 4, 5, 6, and 7 longer than rabeprazole.. Lafutidine 10 mg produces a prompter rise in intragastric pH than rabeprazole 20 mg in fasting and postprandial Helicobacter pylori-negative male subjects.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Acetamides; Administration, Oral; Adult; Benzimidazoles; Cross-Over Studies; Drug Administration Schedule; Gastric Acid; Gastric Acidity Determination; Heartburn; Humans; Hydrogen-Ion Concentration; Male; Monitoring, Physiologic; Omeprazole; Piperidines; Postprandial Period; Pyridines; Rabeprazole; Reference Values; Risk Assessment; Time Factors; Treatment Outcome

We evaluated the efficacy and safety of a twice-daily dosage regimen of cisapride 20 mg in relieving the symptoms of mild-moderate gastroesophageal reflux disease (GERD) in patients with moderate intensity heartburn and no history of erosive esophagitis.. After a 2-wk, single-blind, placebo run-in period, 398 patients who continued to experience moderate intensity heartburn were randomized to either placebo (n = 196) or cisapride 20 mg (n = 202) twice daily for 4 wk.. Compared with placebo, cisapride significantly reduced scores for daytime and nighttime heartburn (p < 0.001), total regurgitation (p < 0.001), eructation (p = 0.04), and early satiety (p = 0.04). Cisapride 20 mg b.i.d. was also superior to placebo in reducing total use of rescue antacid medication (p < 0.001); reducing, in concordance analyses, daytime and nighttime heartburn with antacid usage (p < 0.001); increasing the percentage of heartburn-free days and antacid-free nights (p < 0.5); and increasing the percentage of patients self-rated as having minimal or better symptomatic improvement (p = 0.01). Cisapride 20 mg b.i.d. was well tolerated. The most common adverse event in the cisapride group was diarrhea, reported by 10% of patients, compared with an incidence of 4% in the placebo group.. Cisapride 20 mg b.i.d. was shown to be effective and safe for the short-term treatment of daytime and nighttime heartburn and for other symptoms associated with mild-moderate GERD.

Topics: Adolescent; Adult; Aged; Antacids; Cisapride; Eructation; Female; Gastroesophageal Reflux; Gastrointestinal Agents; Heartburn; Humans; Male; Middle Aged; Piperidines; Single-Blind Method

Few studies have specifically addressed the management of the symptoms of gastro-oesophageal reflux disease, and there are no comparative data in this respect for acid pump inhibitors and prokinetic agents.. Following endoscopy 424 patients presenting with heartburn as the predominant symptom of gastro-oesophageal reflux disease were randomized to treatment with omeprazole 20 or 10 mg once daily, or cisapride 10 mg four times daily, in a double-blind, double-dummy, parallel group, multicentre study. Symptoms and quality of life were assessed at 4 weeks. Patients still experiencing heartburn continued therapy for a further 4 weeks and the assessments were repeated.. At 4 weeks, heartburn was resolved in 65% (95% CI: 57-73%), 56% (48-64%) and 41% (32%-49%) of patients treated, respectively, with omeprazole 20 mg and 10 mg once daily, and cisapride. Both omeprazole doses were significantly more effective than cisapride (P < 0.01). The same order of efficacy was observed regardless of the presence of erosive oesophagitis. Regurgitation and epigastric pain also improved to a greater degree with omeprazole than with cisapride. Quality of life was improved in all treatment groups, and the improvement in the reflux dimension of the Gastrointestinal Symptom Rating Scale (GSRS) score was significantly different between groups (P = 0.002).. Omeprazole 20 or 10 mg once daily is significantly more effective than cisapride in the resolution of heartburn, regardless of the presence of erosive oesophagitis, and this is accompanied by an improvement in patient quality of life.

Topics: Adult; Anti-Ulcer Agents; Cisapride; Double-Blind Method; Enzyme Inhibitors; Esophagitis; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Omeprazole; Piperidines; Proton Pump Inhibitors; Quality of Life

Successful treatment of gastro-oesophageal reflux disease (GORD) has traditionally been assessed as healing of reflux oesophagitis, which may not be relevant in patients with moderate disease. In these patients symptom relief and patient satisfaction with therapy are of fundamental importance. Cisapride has well-documented prokinetic effects and may be well suited for long-term therapy of GORD, but its effectiveness in purely symptomatic treatment is unknown. We therefore compared two dosage regimens of cisapride with placebo over a period of 6 months in patients with evidence of gastrooesophageal reflux, initially treated with antisecretory medication, with regard to maintaining symptom relief and satisfaction with treatment.. Five hundred and thirty-five patients with reflux oesophagitis grade 1 (n = 293) or 2 (n = 124) or with no reflux oesophagitis but pathologic 24-h pH-metry (n = 118) achieved satisfactory symptom relief with an H2-receptor antagonist or proton pump inhibitor within 4-8 weeks. In a double-blind randomized, parallel-group study, they were then treated with cisapride, 20 mg at night or 20 mg twice daily, or placebo and followed up for a maximum period of 6 months. Relapse was defined as dissatisfaction with therapy or an average consumption of more than two antacid tablets a day.. Median time to relapse was 63 days for cisapride, 20 mg twice daily; 59 days for cisapride, 20 mg at night; and 49 days for placebo. Time to relapse was not significantly different (P = 0.09). Presence and grade of oesophagitis at base line, type of therapy before randomization, and pattern of non-reflux symptoms at base line did not influence these findings significantly.. The study indicates that cisapride is of limited value in maintenance therapy of GORD in patients in whom symptom relief has been accomplished with potent antisecretory medication. This 'step-down' approach to therapy seems disadvantageous in the long-term therapy of GORD.

Topics: Abdominal Pain; Cisapride; Constipation; Diarrhea; Drug Administration Schedule; Endoscopy; Esophagitis, Peptic; Female; Flatulence; Gastroesophageal Reflux; Gastrointestinal Agents; Heartburn; Humans; Male; Middle Aged; Piperidines; Recurrence; Remission Induction; Severity of Illness Index; Time Factors

To assess the efficacy of cisapride therapy in relieving symptoms of functional dyspepsia.. After a 2-week placebo run-in period, 61 out of 74 patients were eligible to enter a 4-week double-blind treatment phase, consisting of treatment with cisapride (10 mg) or placebo tablets t.d.s. Gastric emptying was assessed scintigraphically at entry to the study. Patients were stratified before treatment into those with or without active chronic (Helicobacter pylori) gastritis. Patients were also classified retrospectively into those with 'reflux-like' dyspepsia (n = 29) and those with 'motility-like' dyspepsia (n = 32).. At the end of the active treatment phase, there was a similar significant (P < 0.001) reduction in total symptom score from baseline in both cisapride (8.9 +/- 0.5 to 5.8 +/- 0.6) and placebo (9.7 +/- 0.6 to 5.5 +/- 0.6) groups. Scores for heartburn and continual bloating were significantly reduced in the cisapride but not the placebo group; improvement was attributable to patients with normal, rather than delayed, rates of gastric emptying. For continual bloating, significant improvement also occurred in the cisapride subgroup without gastritis, but not in the subgroup with gastritis (mean symptom score reduction 0.48 +/- 0.18, P = 0.03). For global evaluation by the investigator and by the patient, the overall improvement rates were not statistically different between cisapride and placebo groups. In those with normal gastric emptying, however, there was a significant (P = 0.01) improvement in general well-being in the cisapride but not in the placebo group.. We were unable to show major differences in the short-term efficacy of cisapride and placebo in functional dyspepsia. There were indications, however, of beneficial effects of cisapride over placebo in those with 'reflux-like' dyspepsia, and in those without gastroparesis.

Topics: Adult; Anti-Ulcer Agents; Cisapride; Double-Blind Method; Dyspepsia; Eructation; Female; Gastric Emptying; Heartburn; Humans; Male; Middle Aged; Nausea; Piperidines; Time Factors

To compare the efficacy of the prokinetic drug cisapride and the antisecretory agent ranitidine in relieving symptoms of functional dyspepsia, as well as their effect on the recurrence of symptoms after the discontinuation of treatment.. A randomized double-blind parallel-group trial of cisapride 30 mg daily and ranitidine 300 mg daily given for 2, 4 or 8 weeks, followed by a 4-week drug-free follow-up of the patients with a good or excellent response. Rescue antacid tablets were allowed only if pain was unbearable.. A total of 203 patients (99 cisapride, 104 ranitidine) with symptoms of functional dyspepsia for more than 4 weeks, after the exclusion of organic disease by endoscopy and sonography or radiology.. Cisapride and ranitidine improved the symptoms of diffuse epigastric pain, postprandial epigastric fullness, epigastric distension, belching, heartburn, regurgitation, and nausea when compared with baseline. Pain at night and gastric discomfort also greatly improved. Cisapride produced a greater reduction in epigastric pain (P = 0.07) and epigastric distension (P = 0.03) scores than ranitidine. Both drugs were equally effective in reducing the concomitant reflux-like symptoms of heartburn and regurgitation. At week 8, 87% of cisapride patients versus 61% of ranitidine patients had an excellent or good result. The deterioration of symptoms during the follow-up phase was limited in both groups. However, after the withdrawal of medication there was a greater reduction in scores in the cisapride group than in the ranitidine group for diffuse epigastric pain (P = 0.05), epigastric distension (P = 0.002), the cluster of six symptoms of epigastric discomfort (P = 0.05), and the cluster of all nine upper gastrointestinal symptoms (P = 0.06). Adverse events occurred in 15 cisapride patients and 18 ranitidine patients, and two of the ranitidine patients were withdrawn from treatment.. Although cisapride and ranitidine both improved the symptoms of functional dyspepsia, cisapride was superior to ranitidine, particularly on the combined evaluation of the response to treatment and the recurrence of symptoms.

Topics: Adult; Antacids; Anti-Ulcer Agents; Cisapride; Double-Blind Method; Dyspepsia; Eructation; Female; Follow-Up Studies; Gastroesophageal Reflux; Gastroscopy; Heartburn; Humans; Male; Nausea; Piperidines; Ranitidine; Recurrence

To evaluate the safety and efficacy of cisapride in patients with gastroesophageal reflux disease.. Patients (N = 177) were randomized to double-blind treatment with cisapride (10 or 20 mg q.i.d.) or placebo for 12 wk. Efficacy was determined by pre- and poststudy endoscopies, symptom assessments by patient and physician, and Maalox consumption. Safety evaluations included vital signs, electrocardiograms, clinical laboratory tests, and reports of adverse events.. Cisapride 10 mg significantly reduced daytime and nighttime heartburn at 4 wk compared with placebo. Cisapride 20 mg reduced both daytime and nighttime heartburn at 4, 8, and 12 wk, compared with placebo, and was also significantly superior to the 10-mg dose at 12 wk. The percent of patients with endoscopic healing was significantly higher with cisapride 20 mg than with placebo [healing: 51 vs 36% (p < or = 0.044)]. Maalox usage declined significantly with cisapride 20 mg compared with placebo. No clinically significant changes in safety variables occurred with cisapride. The most frequently reported adverse events in the cisapride group were diarrhea, headache, and sinusitis.. Cisapride 10 and 20 mg q.i.d. were safe and well tolerated in a population of patients with mild-to-moderate gastroesophageal reflux disease. Both symptoms and endoscopic grade improved after 12 wk of treatment with cisapride 20 mg q.i.d.

Topics: Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; Cisapride; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Esophagitis, Peptic; Esophagoscopy; Female; Gastroesophageal Reflux; Heartburn; Humans; Magnesium Hydroxide; Male; Middle Aged; Piperidines; Time Factors

Combined treatment with cimetidine 1 g daily and cisapride 40 mg daily in patients with endoscopically diagnosed severe reflux oesophagitis was compared with single drug therapy (cimetidine and placebo). At the end of the six to 12 weeks treatment, 11 (46%) of the 24 patients under single drug therapy were endoscopically healed and three were improved. In contrast, 16 (70%) of the 23 patients under combined therapy were healed and all of the remainder were improved (p = 0.025). The severity of diurnal and nocturnal heartburn, decreased significantly more (p less than 0.05) on cimetidine + cisapride than on cimetidine + placebo. The combined treatment was well tolerated. These results suggest that combined therapy with cisapride and cimetidine may be useful in patients with severe reflux oesophagitis.

Topics: Adult; Aged; Cimetidine; Cisapride; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Esophagitis, Peptic; Esophagoscopy; Female; Heartburn; Humans; Male; Middle Aged; Piperidines; Random Allocation

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Acetamides; Benzimidazoles; Gastric Acid; Gastric Acidity Determination; Heartburn; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Hydrogen-Ion Concentration; Omeprazole; Piperidines; Prognosis; Proton Pump Inhibitors; Pyridines; Rabeprazole; Severity of Illness Index; Treatment Outcome

Topics: Adult; Aged; Anti-Ulcer Agents; Barium Sulfate; Chest Pain; Cisapride; Contrast Media; Esophagitis, Peptic; Esophagoscopy; Female; Gastrectomy; Gastric Acid; Gastroesophageal Reflux; Gastrointestinal Agents; Heartburn; Humans; Hydrogen-Ion Concentration; Lymph Node Excision; Male; Manometry; Middle Aged; Patient Selection; Piperidines; Radiography; Stomach Neoplasms; Vagotomy, Truncal

Topics: Cisapride; Gastrointestinal Agents; Heartburn; Humans; Piperidines; United States; United States Food and Drug Administration

Topics: Cisapride; Clinical Trials as Topic; Esophagitis, Peptic; Gastroesophageal Reflux; Heartburn; Humans; Piperidines; Posture

Increasing the resting lower esophageal sphincter (LES) tone is a useful method of preventing gastroesophageal reflux. The effects of a new antiemetic, domperidone, on LES were studied in 28 subjects. Group I included eight normal nonpregnant control subjects. The remaining 20 pregnant women were divided into two groups, Group II and III--ten parturients without and ten with symptoms of heartburn. Domperidone increased LES pressure by 19, 11 and 10 cm H2O in Groups I, II and III, respectively (P less than 0.05). Domperidone may be a valuable premedicant in some patients to decrease the chance of gastro-esophageal reflux.

Topics: Adolescent; Adult; Anesthesia, Obstetrical; Benzimidazoles; Domperidone; Esophagogastric Junction; Female; Gastroesophageal Reflux; Heartburn; Humans; Muscle Tonus; Piperidines; Preanesthetic Medication; Pregnancy; Pressure